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Medical research on diclofenac
Exacerbation of psoriatic skin lesions in a patient with psoriatic arthritis receiving adalimumab.
J Clin Pharm Ther. 2008 Jun; 33(3): 321-5
Borrás-Blasco J, Gracia-Perez A, Nuñez-Cornejo C, Rosique-Robles JD, Mateu-Puchades A, Casterá MD, Rubio-Fabra M
OBJECTIVE: To report a case of a patient with psoriatic arthritis (PsA) receiving adalimumab, who developed an exacerbation of palmoplantaris pustulosa psoriasis. CASE SUMMARY: A 38-year-old woman diagnosed with PsA had received treatment with non-steroidal antiinflammatory drugs. Two months prior to admission, the patient had a Disease Activity Score of 3.8; diclofenac therapy was suspended and physicians considered treatment with adalimumab. Chest X-rays were normal and the tuberculin skin test was negative. Treatment with adalimumab was started. After the third dose of adalimumab, the patient developed an exacerbation of psoriatic skin lesions on palms and soles. The clinical course was consistent with an exacerbation of palmoplantaris pustulosa psoriasis. Adalimumab treatment was suspended. The patient was treated with oral methotrexate 2.5 mg once weekly. One month after methrotexate was started, the patient developed a severe alopecia. Methrotexate therapy was suspended. Three months later, the patient continued with psoriatic skin lesions on palms and soles. Treatment with Psoralen and ultraviolet A therapy was initiated and the patient condition improved without occurrence of psoriatic skin lesions in the next 4 months. DISCUSSION: Cases of worsening or exacerbation of psoriatic skin lesions induced by anti-tumour necrosis factor (TNF) agents in patients diagnosed PsA are infrequently described in the literature. The most likely cause of the exacerbation of palmoplantaris pustulosa psoriasis in this case was considered to be adalimumab because of the close temporal relationship between exposure to the drug and onset of symptoms. Adalimumab was the only identifiable precipitant that the patient encountered before the exacerbation of psoriasis developed. In accordance with the data obtained and based on the Naranjo algorithm, the adverse reaction could be considered probable. Conclusions: Patients initiated on adalimumab therapy should be closely monitored for the development of exacerbation of psoriasis. Clinicians should be aware of this rare adverse effect of this anti-TNF drug.
Pharmaceutical residues in the river Rhine-results of a one-decade monitoring programme.
J Environ Monit. 2008 May; 10(5): 664-70
Sacher F, Ehmann M, Gabriel S, Graf C, Brauch HJ
In this paper, results of an extensive monitoring programme for pharmaceutical residues in the river Rhine are presented. For one decade (1997 until 2006), the occurrence of widely used human pharmaceuticals like analgesics, lipid regulators, antiepileptics and others has been studied at four locations along the river Rhine. The results of more than 500 analyses clearly prove that compounds such as carbamazepine or diclofenac are regularly found in the river Rhine in concentrations up to several hundred ng per litre. Combining concentration levels with data on water flow enables the calculation of transports, which e.g. for carbamazepine or diclofenac were in the range of several tons per year. The evaluation of the long-term monitoring data shows that only a slight decrease in concentration levels as well as in annual transports can be observed and thus the contamination of the river Rhine by pharmaceutical residues during the last decade has to be regarded as almost constant. Seasonal variations can be detected for bezafibrate, diclofenac and ibuprofen, for which the concentrations are much lower in the summer months. A more effective removal during wastewater treatment in the warmer periods of the year seems to be the major reason for those variations. For carbamazepine, no comparable seasonal effect can be found.
Investigation of PEGylated Derivatives of Rosin as Sustained Release Film Formers.
AAPS PharmSciTech. 2008; 9(1): 105-11
Nande VS, Barabde UV, Morkhade DM, Joshi SB, Patil AT
The purpose of the present study was to investigate the potential use of two PEGylated derivatives of rosin (PD) as sustained release film forming materials. The derivatives differed chemically by their acid numbers-PD-1 with 120.93 and PD-2 with 88.19. The derivative films were characterized for surface morphology, water uptake-weight loss, angle of contact, water vapor transmission rate, mechanical properties and permeability study. Dissolution of diclofenac sodium (DS) and propranolol hydrochloride (PHL) as model drugs was studied from coated pellets. The films of derivatives with and without plasticizers were smooth and continuous. PD-2 films developed greater numbers of pores when in contact with phosphate buffer pH 6.8. The low weight loss, low angles of contact and high water vapor transmission rate of PD-2 films were related to presence of higher concentration of PEG esters. Higher tensile strength and percent elongation of PD-2 films was due to greater degree of internal plasticization of the derivative. The permeability of films to model drugs propranolol hydrochloride and diclofenac sodium was inversely proportional to the film thickness and dibutyl phthalate concentration in them; the permeability being greatest in PD-2 films containing 10% PEG 200. Dissolution rate of propranolol hydrochloride was higher from the coated pellets. The dissolution data followed zero order, Baker-Lonsdale equation and Hixon-Crowell equation of release kinetics with high correlation coefficients. The mechanism of drug release from these coated systems however followed class II transport (n > 1.0). The derivatives investigated could successfully retard release of the model drugs and offers an alternative to the conventionally used polymers.
J Opioid Manag. 2008 Jan-Feb; 4(1): 49-53
Ng A, Swami A, Smith G, Emembolu J
The aim of this double-blind double-dummy randomized controlled trial was to investigate if there was any difference in analgesia between the maximum recommended doses of rectal diclofenac and iv parecoxib after laparoscopic sterilization. The authors studied 55 ASA I-II patients undergoing gynecological laparoscopy; each patient received either preoperative rectal diclofenac 100 mg and 2 mL of normal saline at induction of anesthesia, or preoperative placebo suppository and 2 mL of parecoxib 40 mg at induction. Pain intensity, sedation, and nausea were measured using a 100-mm visual analogue scale on awakening and at 1, 2, and 3 hour postoperatively. Median (interquartile range) pain intensity at rest on awakening and at 1, 2, and 3 hour postoperatively were 15 (0-40), 37 (10-56), 16 (6-29), and 13 (2-32) mm, respectively, in the parecoxib group, and 3 (0-34), 22 (5-45), 24 (6-37), and 10 (4-21) mm, respectively, in the diclofenac group. There was no significant difference in these scores. Furthermore, there was no significant difference between the two groups in sedation, nausea, rescue analgesia, or rescue antiemetic consumption. Preoperative rectal diclofenac 100 mg and parecoxib 40 mg iv at induction of anesthesia were found to have equianalgesic effects after laparoscopic sterilization. Both drugs appear to be useful after short anaesthetics.
Pain Res Manag. 2008 Mar-Apr; 13(2): 103-10
Beaulieu AD, Peloso PM, Haraoui B, Bensen W, Thomson G, Wade J, Quigley P, Eisenhoffer J, Harsanyi Z, Darke AC
OBJECTIVE: The present study was a randomized, parallel, double-blind comparison between controlled-release (CR) tramadol and sustained-release (SR) diclofenac in patients with chronic pain due to osteoarthritis of the hips and/or knees. METHODS: Patients with at least moderate pain intensity, and having received analgesics over the past three months, underwent a two- to seven-day washout of current analgesics before initiation of 200 mg CR tramadol or 75 mg SR diclofenac. During the eight-week study, patients returned to the clinic biweekly. CR tramadol doses were titrated to a maximum of 200 mg, 300 mg or 400 mg per day. SR diclofenac doses were titrated to 75 mg or 100 mg once daily, or 75 mg twice a day based on pain relief and the presence of side effects. For rescue analgesic, patients took acetaminophen as needed, up to 650 mg three times a day. RESULTS: Forty-five patients on CR tramadol and 52 patients on SR diclofenac were evaluable. Significant improvements from prestudy treatment were shown for visual analogue scale pain (P=0.0001), stiffness (P
Sol-gel processed porous silica carriers for the controlled release of diclofenac diethylamine.
J Biomed Mater Res B Appl Biomater. 2008 Apr 24;
Czarnobaj K, Czarnobaj J
Silica xerogels doped with diclofenac diethylamine were prepared by the sol-gel method from a hydrolysed tetraethoxysilane (TEOS) solution containing diclofenac diethylamine. Two different catalysts, drying conditions and levels of water content were used to alter the microstructure of the silica xerogels. The aim of this study was to determine the rate of Diclofenac release from the silica xerogels. This in vitro study showed that the sol-gel method is useful for entrapping Diclofenac in the pores of xerogels. It also showed that, in vitro, Diclofenac is released from the silica xerogel, through the pores, by diffusion. Base-catalysed gels proved to be much more effective than acid-catalyzed gels. (c) 2008 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 2008.
Nonaspirin NSAIDs, Cyclooxygenase 2 Inhibitors, and the Risk for Stroke.
Stroke. 2008 Apr 24;
Roumie CL, Mitchel EF, Kaltenbach L, Arbogast PG, Gideon P, Griffin MR
BACKGROUND AND PURPOSE: There is limited information regarding the cerebrovascular safety of cyclooxygenase 2 inhibitors (coxibs) and noncoxib nonsteroidal antiinflammatory drugs (NSAIDs). We determined whether specific NSAIDs, including coxibs, are associated with risk of stroke. METHODS: Retrospective cohort study among Tennessee Medicaid enrollees aged 50 to 84 years between January 1, 1999 and December 31, 2004. Noninstitutionalized persons with continuous enrollment in Medicaid and no stroke or other serious medical illness in the year before cohort entry were included. The 7 most common NSAIDs were examined: celecoxib, rofecoxib, valdecoxib, ibuprofen, naproxen, diclofenac, and indomethacin. Nonuse of NSAIDs was the reference group. Because new use is less susceptible to bias, we conducted a similar analysis confined to new users. The outcome was hospitalization for an incident cerebrovascular event: ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage. RESULTS: The cohort included 336 906 persons, with 989 826 person-years of follow-up, and 4354 stroke hospitalizations. There were 4.51 strokes per 1000 person years in the nonuse group, 5.15 strokes per 1000 person years (adjusted HR 1.28, 95% CI 1.06, 1.53) with rofecoxib use, and 5.95 strokes per 1000 person years (adjusted HR 1.41, 95% CI 1.04, 1.91) with valdecoxib use. New use of rofecoxib and valdecoxib led to 6.06 (adjusted HR 1.46 95% CI 1.08, 1.98) and 6.19 (adjusted HR 1.39, 95% CI 0.74, 2.59) strokes per 1000 person years respectively. No other NSAID significantly increased the risk of incident stroke. CONCLUSIONS: Our results indicate an increased risk of stroke with current use of two highly selective coxibs, rofecoxib and valdecoxib, also shown to increase cardiovascular risk. These results also provide some reassurance about other specific NSAIDs regarding stroke risk.
Laparoscopic surgery using spinal anesthesia.
JSLS. 2008 Apr-Jun; 12(2): 133-8
Sinha R, Gurwara AK, Gupta SC
BACKGROUND: Laparoscopic abdominal surgery is conventionally done under general anesthesia. Spinal anesthesia is usually preferred in patients where general anesthesia is contraindicated. We present our experience using spinal anesthesia as the first choice for laparoscopic surgery for over 11 years with the contention that it is a good alterative to anesthesia. METHODS: Spinal anesthesia was used in 4645 patients over the last 11 years. Laparoscopic cholecystectomy was performed in 2992, and the remaining patients underwent other laparoscopic surgeries. There was no modification in the technique, and the intraabdominal pressure was kept at 8mm Hg to 10mm Hg. Sedation was given if required, and conversion to general anesthesia was done in patients not responding to sedation or with failure of spinal anesthesia. Results were compared with those of 421 patients undergoing laparoscopic surgery while under general anesthesia. RESULTS: Twenty-four (0.01%) patients required conversion to general anesthesia. Hypotension requiring support was recorded in 846 (18.21%) patients, and 571(12.29%) experienced neck or shoulder pain, or both. Postoperatively, 2.09% (97) of patients had vomiting compared to 29.22% (123 patients) of patients who were administered general anesthesia. Injectable diclofenac was required in 35.59% (1672) for abdominal pain within 2 hours postoperatively, and oral analgesic was required in 2936 (63.21%) patients within the first 24 hours. However, 90.02% of patients operated on while under general anesthesia required injectable analgesics in the immediate postoperative period. Postural headache persisting for an average of 2.6 days was seen in 255 (5.4%) patients postoperatively. Average time to discharge was 2.3 days. Karnofsky Performance Status Scale showed a 98.6% satisfaction level in patients. CONCLUSIONS: Laparoscopic surgery done with the patient under spinal anesthesia has several advantages over laparoscopic surgery done with the patient under general anesthesia.
J Clin Pharmacol. 2008 Apr 23;
Schwartz JI, Dallob AL, Larson PJ, Laterza OF, Miller J, Royalty J, Snyder KM, Chappell DL, Hilliard DA, Flynn ME, Cavanaugh PF, Wagner JA
We determined cyclo-oxygenase-1 and cyclo-oxygenase-2 inhibition in healthy middle-aged subjects (41-65 years) randomly assigned to four 7-day treatment sequences of etoricoxib 90 mg every day, celecoxib 200 mg twice a day, diclofenac 75 mg twice a day, or placebo in a double-blind, randomized, 4-period crossover study. Maximum inhibition of thromboxane B2 (cyclo-oxygenase-1 activity) in clotting whole blood on day 7 (0-24 hours postdose) was the primary endpoint. Inhibition of lipopolysaccharide-induced prostaglandin E2 in whole blood (cyclo-oxygenase-2 activity) was assessed on day 7 (0-24 hours postdose) as a secondary endpoint. Diclofenac had significantly greater maximum inhibition of thromboxane B2 versus each comparator (P < .001); placebo 2.4% (95% confidence interval: -8.7% to 12.3%), diclofenac 92.2% (91.4% to 92.9%), etoricoxib 15.5% (6.6% to 23.5%), and celecoxib 20.2% (11.5% to 28.1%). Prostaglandin E2 synthesis was inhibited with a rank order of potency of diclofenac > etoricoxib > celecoxib. In summary, at doses commonly used in rheumatoid arthritis, diclofenac significantly inhibits both cyclo-oxygenase-1 and cyclo-oxygenase-2, whereas etoricoxib and celecoxib significantly inhibit cyclo-oxygenase-2 and do not substantially inhibit cyclo-oxygenase-1.
[What is new about nonsteroidal antiinflamatory drugs?]
Pol Merkur Lekarski. 2007 Dec; 23(138): 454-8
Dzielska-Olczak M
NSAIDs contain nonselective cyclooksygenase inhibitors (for COX-1 and COX-2), inhibitors to the preferential COX-2, the coxibs (sulphonamides, methylsulphones, phenylacethic acid derivatives) with 1000 fold selectivities for COX-2. COX-2 enzyme isoform are constitutively expressed in normal gastric tissue in animals and humans, in the cardiovascular system, renal, central nervous system and other. COX-2 is involved in the ischemic preconditioning mechanism and sulphones have a prooxidant activity. COX-2 inhibitors increased risk for thrombotic cardiovascular events. Long-term study VIGOR, CLASS, TARGET MEDAL revealed that celecoxib, rofecoxib, lumiracoxib, etoricoxib significantly reduced the risk of major gastrointestinal effects (ulcers, perforations, bleeding) than nonselective NSAIDs, but the rates of complicated upper gastrointestinal events were similar for etoricoxib and diclofenac. Only in VIGOR trial incidence of cardiovascular events was greater. No evidence that concomitant ASA reduced risk for cardivascular events. Potential differences in cardiovascular outcomes with the selective COX-2 inhibitors may be due to differences in the drugs molecular structures, pharmacokinetics and pharmacodynamics. In the "prothrombotic environment" contribution disorders in the balance between thromboxan A2 and prostacyclin, increased aggregation plaque, hypertension, endothelial cell dysfunction, impaired angiogenesis. Moreover COX-2 may plays a crucial role in atherosclerotic plaque stability or instability. The cardiovascular risk may be dose related and depends on duration therapy, variable selectivity for COX-2.